Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470009
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Portable Neuromodulation Stimulator PoNS Therapy for Gait and Balance Deficits in Chronic Stroke Survivors A Randomized Controlled Trial
Sponsor:
Helius Medical Inc
Organization:
Helius Medical Inc
Study Overview
Official Title:
Portable Neuromodulation Stimulator PoNS Therapy for Gait and Balance Deficits in Chronic Stroke Survivors A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double blind randomized placebo controlled interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors
Detailed Description:
Double blind randomized placebo controlled interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors
The Study Intervention Therapy is a therapeutic rehabilitation program that uses the PoNS device Active or Sham in conjunction with individualized physical exercise regimen
The data from this prospective double-arm multi-site study that will enroll 40 subjects at 2-3 different clinical sites will be used to augment efficacy and safety data obtained in the RCT which will randomize 60 subjects 11 into either active PoNS combined with DGB training versus DGB training with a sham device and the OLS which will enroll 30 subject into one active treatment arm The totality of the proposed clinical evidence spans 3-4 sites and approximately 120 participants
Eligible study participants will be randomized to either active PoNS Study Intervention device active or placebo PoNS Study Intervention device sham Participants will work with a study physical therapist - trained in PoNS Therapy by HMI Medical and registered as a PoNS Trainer Trainer
The Trainer will prepare a DGB training exercise program appropriate to the participants ability level and instruct on how to perform the breathing and awareness mindfulness training BAT To ensure patients safety during rehabilitation at home the Trainer may assign a DGB training program slightly different from the one performed in clinic
All participants will undergo a total of twelve weeks of DGB training program combined with active or sham devices study treatment performed both in clinic 4 weeks Part 1 supervised by the Trainer and at home 8 weeks Part 2 mostly unsupervised At the end of the treatment period they will be asked to return to the clinic site for the follow-up visit 12 weeks after the end of the treatment period as shown below
Participants will receive individualized balance and gait rehabilitation protocols appropriate to their ability level and breathing and awareness mindfulness training Table 1 During the training sessions in clinic and subsequently during at-home training period the trainer can adjust flex the DGB training based on the participants individual response to the Study Intervention Therapy Table 1 During Part 2 the Trainer will follow-up weekly with participants in the clinic
Table 1
Twelve weeks after completing the 12-week treatment phase of the study participants will be required to return to the clinic for the final assessment of treatment effect During the 12-week follow-up period Part 3 participants will no longer utilize the Study Intervention device but will still be encouraged to continue with their physical rehabilitation program for the duration follow-up period until the final study visit
The Study Intervention Therapy is a therapeutic rehabilitation program that uses the PoNS device Active or Sham in conjunction with individualized physical exercise regimen
The data from this prospective double-arm multi-site study that will enroll 40 subjects at 2-3 different clinical sites will be used to augment efficacy and safety data obtained in the RCT which will randomize 60 subjects 11 into either active PoNS combined with DGB training versus DGB training with a sham device and the OLS which will enroll 30 subject into one active treatment arm The totality of the proposed clinical evidence spans 3-4 sites and approximately 120 participants
Eligible study participants will be randomized to either active PoNS Study Intervention device active or placebo PoNS Study Intervention device sham Participants will work with a study physical therapist - trained in PoNS Therapy by HMI Medical and registered as a PoNS Trainer Trainer
The Trainer will prepare a DGB training exercise program appropriate to the participants ability level and instruct on how to perform the breathing and awareness mindfulness training BAT To ensure patients safety during rehabilitation at home the Trainer may assign a DGB training program slightly different from the one performed in clinic
All participants will undergo a total of twelve weeks of DGB training program combined with active or sham devices study treatment performed both in clinic 4 weeks Part 1 supervised by the Trainer and at home 8 weeks Part 2 mostly unsupervised At the end of the treatment period they will be asked to return to the clinic site for the follow-up visit 12 weeks after the end of the treatment period as shown below
Participants will receive individualized balance and gait rehabilitation protocols appropriate to their ability level and breathing and awareness mindfulness training Table 1 During the training sessions in clinic and subsequently during at-home training period the trainer can adjust flex the DGB training based on the participants individual response to the Study Intervention Therapy Table 1 During Part 2 the Trainer will follow-up weekly with participants in the clinic
Table 1
Twelve weeks after completing the 12-week treatment phase of the study participants will be required to return to the clinic for the final assessment of treatment effect During the 12-week follow-up period Part 3 participants will no longer utilize the Study Intervention device but will still be encouraged to continue with their physical rehabilitation program for the duration follow-up period until the final study visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None